Provitus Dabrowscy ,Malesa S.J. — FDA Facility Profile

FEI 3009968719

Provitus Dabrowscy ,Malesa S.J. is an FDA-inspected facility (FEI 3009968719) located in Zambrow, PL. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Sep 6, 2022: No Action Indicated (NAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Jan 31, 2014
Warning letters
1 listed by FDA for this FEI, latest Jul 17, 2014
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 6, 2022No Action Indicated (NAI)No citations listed
Aug 28, 2018Voluntary Action Indicated (VAI)Code - required elements (21 CFR 114.80(b))
Jan 31, 2014Official Action Indicated (OAI)Thermal processing - timing devices (21 CFR 113.87(d))
No TID (21 CFR 113.40(a)(1))
Steam controller (21 CFR 113.40(a)(4))
Present each retort, accurate (21 CFR 113.40(a)(2))
and 4 more

Facility details

Company
Provitus Dabrowscy ,Malesa S.J.
Location
Zambrow (PL)
Source
inspections

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.